Drug Enforcement D-0059-2023

Failed Stability Specifications

Status

Terminated

Classification

Class III

Report Date

November 23, 2022

Termination Date

March 16, 2023

Product Information

Product description
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.
Product quantity
2,333 vials
Reason for recall
Failed Stability Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Within the U.S Market - PA, AL, KY, TN

Location & Firm

Recalling firm
Aadi Bioscience
Address
17383 W Sunset Blvd Ste A250, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0059-2023
Event ID
91019
Recall initiation date
October 13, 2022
Center classification date
November 14, 2022
Code info
Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.
More code info
—